Recruiting
Phase 1
Phase 2

ETX-929

Sponsor:

Ensem Therapeutics

Code:

NCT07912593

Conditions

Metastatic Colorectal Cancer (CRC)

Pancreatic Ductal Adenocarcinoma (PDAC)

Non-squamous, Non-Small Cell Lung Cancer

Endometrial Adenocarcinoma

Ovarian Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ETX-929 dose escalation

ETX-929 dose escalation in combination with cetuximab

Study Details

Brief summary:

This is a Phase 1/2, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.

Conditions

Metastatic Colorectal Cancer (CRC)

Pancreatic Ductal Adenocarcinoma (PDAC)

Non-squamous, Non-Small Cell Lung Cancer

Endometrial Adenocarcinoma

Ovarian Adenocarcinoma

Study ID

NCT07912593

Start date

Oct 22, 2026

Status verified date

Oct, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.
  • Tumor harboring a KRAS mutation.
  • An ECOG performance status score of 0 or 1.
  • Adequate organ function.

Exclusion Criteria:

  • Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.
  • Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
  • Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.
  • Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.
  • Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A Dose Escalation Monotherapy

Part A is a dose escalation monotherapy of ETX-929 in advanced solid tumors with KRAS alterations.

experimental: Part B Dose Escalation Combination Therapy

Part B is a dose escalation combination therapy in advanced solid tumors with KRAS alterations. The study treatment will be ETX-929, a pan-KRAS inhibitor, in combination with cetuximab at a fixed dose.

experimental: Part C Dose Expansion

Part C will evaluate ETX-929 at the recommended Phase 2 dose (RP2D\[s\]) established in Part A.

experimental: Part D Dose Expansion Combination Therapy

Part D will evaluate ETX-929 at the recommended Phase 2 dose (RP2D\[s\]) established in Part A.

Interventions

ETX-929 dose escalation

ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule that will be taken once per day in 21-day cycles, to evaluate escalating dose levels.

ETX-929 dose escalation in combination with cetuximab

ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule. ETX-929 will be taken in combination with cetuximab in 28-day cycles, to evaluate escalating dose levels. EXT-929 is an oral capsule that will be taken once per day. Cetuximab will be administered intravenously every two weeks.

Primary outcome measure

  • Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B [ Time Frame: First Cycle (21 days in Part A and 28 days in Part B) ]
  • Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B [ Time Frame: Average of 6 months ]
  • Select the Recommended Phase 2 Dose(s) (RP2D) [ Time Frame: Average of 6 months ]
  • Evaluate efficacy of ETX-929 monotherapy and ETX-929 in combination with cetuximab at the RP2D(s) in Part B and Part D [ Time Frame: Average of 6 months ]

Central Contacts and Locations

Central contacts

Lori Cykowski

1-617-383-4993lori.cykowski@Ensemtx.com

Locations

NEXT

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

703-783-4518mdelarosa@nextoncology.com

Principal Investigator:

Alex Spira, MD, PhD, FACP

More Information

Sponsor

Ensem Therapeutics

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • KRAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Ensem Therapeutics on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.